Needle-Sized device could reveal which bladder cancer drug works best
NCT ID NCT06204614
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage study tests a tiny implantable device that releases very small amounts of several cancer drugs directly into bladder tumors. The goal is to see if the device is safe and can help doctors figure out which drugs kill the tumor best. Only 18 people with muscle-invasive bladder cancer who are already scheduled for bladder removal surgery will take part.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- implantable microdevice releasing microdoses of methotrexate, carboplatin, avelumab, and paclitaxel
- What this could lead to
- If successful, this could lead to a way to test multiple cancer drugs directly in a patient's tumor, helping doctors choose the most effective treatment without exposing the whole body to side effects.
- What could go wrong
- This is a very early, small study with only 18 people, focused on safety and feasibility, not on curing cancer. The device may not work as hoped, and there is a small risk of side effects from the procedure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 120 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients must have the ability to understand and the willingness to sign a written informed consent document. 2. Participants must have confirmed clinically localized bladder cancer with histology of urothelial cell carcinoma or variant histology and radiographic imaging consistent with stage T2-T3 N0 disease. Patients must be planned for cystectomy as part of their clinical care. The lesion planned for excision must be at least 1cm in size. 3. Participants must be 18 years of age or older. Patients must have the ability to understand and the willingness to sign a written informed consent document. 4. Participants must have confirmed clinically localized bladder cancer with histology of urothelial cell carcinoma or variant histology and radiographic imaging consistent with stage T2-T3 N0 disease. Patients must be planned for cystectomy as part of their clinical care. The lesion planned for excision must be at least 1cm in size. 5. Participants must be 18 years of age or older. Patients must have the ability to understand and the willingness to sign a written informed consent document. 6. Participants must have confirmed clinically localized bladder cancer with histology of urothelial cell carcinoma or variant histology and radiographic imaging consistent with stage T2-T3 N0 disease. Patients must be planned for cystectomy as part of their clinical care. The lesion planned for excision must be at least 1cm in size. 7. Participants must be 18 years of age or older. 8. Participants must be evaluated by a medical oncologist who will determine the clinically appropriate treatment strategy based on clinical history and extent of disease. 9. Patients must be deemed medically stable to undergo both percutaneous procedures and standard-of-care surgical procedures. 10. Participants will undergo laboratory testing within 30 days prior to the procedure (or within 72 hours if there has been a change in the clinical status since the initial blood draw). Patients must have absolute neutrophil count ≥1,000/mcL, platelets ≥50,000/mcL, PT (INR) 1.5 and PTT\<1.5x control. 11. Participants must have undergone CT or MRI that assesses the extent of disease and allows the research team to assess for study eligibility. This will have been done as part of the standard-of-care. 12. The participant's case must be reviewed by the treating physician to assess the following factors: * Patient is clinically stable to undergo microdevice implantation and surgical procedures * Patient has sufficient volume of disease to allow implantation of the microdevice * Patient has a lesion for which the microdevice is a) amenable to percutaneous placement, and b) amenable to removal at the time of surgery 13. Patients must be willing to undergo research-related genetic sequencing (somatic and germline) and data management, including the deposition of de-identified genetic sequencing data in NIH central data repositories. 14. Patients must be agree to remain abstinent or use contraceptive measures for the duration of the study period Exclusion Criteria: 1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit the safety of a biopsy and/or surgery. 2. Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or biopsy procedures (detailed below in section 5.1.2.1).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can two drugs spare the bladder in aggressive bladder cancer?
- A simple blood draw could detect bladder Cancer's return — a trial puts it to the test
- New combination aims to save bladders in Muscle-Invasive cancer
- Bladder cancer radiation trial halted early – only 2 patients enrolled
- Could fewer radiation sessions be just as effective for bladder cancer?
- Gene therapy joins forces with chemo and immunotherapy to fight bladder cancer